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US Food and Drug Administration (FDA) - Establishment Registration

FDA Registered Companies - Updated May 2006

What is Establishment Registration?

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration.
FDA Registrations
FDA Registrations
FDA Registrations
FDA Registrations


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Establishment Owner/Operator
OVAL INDUSTRIES, LTD.
BARKAN,  IS.
Unregistered Foreign Lister;  
OVAL INDUSTRIES, LTD.
BARKAN,  IS.
OVEN INDUSTRIES, INC.
MECHANICSBURG,  PA,  US.
Contract Manufacturer;  
OVEN INDUSTRIES, INC.
MECHANICSBURG,  PA ,  US.
OVERCOM TRADE, INC.
MIAMI,  FL,  US.
Initial Importer;   Repackager/Relabeller;  
OVERCOM TRADE, INC.
MIAMI,  FL ,  US.
OVERSEAS CONTRACT SERVICES, INC.
WILMINGTON,  DE,  US.
Initial Importer;  
OVERSEAS CONTRACT SERVICES, INC.
WILMINGTON,  DE ,  US.
OVERSEAS TABAC CO.
ANDHERI (W), MUMBAI BOMBAY,  IN.
Foreign Exporter;   Manufacturer;  
OVERSEAS TABAC CO.
ANDHERI (W), MUMBAI BOMBAY,  IN.
OVERSTOCK.COM, INC.
SALT LAKE CITY,  UT,  US.
Initial Importer;  
OVERSTOCK.COM, INC.
SALT LAKE CITY,  UT ,  US.
OVULATION CALCULATORS, INC.
CHICAGO,  IL,  US.
Specification Developer;  
HECTOR VIDES
CHICAGO,  IL ,  US.
OVUSOFT, LLC.
HAMPTON,  VA,  US.
Manufacturer;  
OVUSOFT, LLC.
HAMPTON,  VA ,  US.
OWANDY SA
CHAMPS SUR MARNE,  FR.
Foreign Exporter;   Manufacturer;  
OWANDY SA
CHAMPS SUR MARNE,  FR.
OWEN MUMFORD USA, INC.
MARIETTA,  GA,  US.
Initial Importer;   Repackager/Relabeller;  
OWEN MUMFORD, LTD.
WOODSTOCK, OXFORDSHIRE,  UK.
OWEN MUMFORD, LTD.
WOODSTOCK, OXFORDSHIRE,  UK.
Manufacturer;  
OWEN MUMFORD, LTD.
WOODSTOCK, OXFORDSHIRE,  UK.
OWENS & MINOR MEDICAL, INC.
BELLEVILLE,  MI,  US.
Initial Importer;  
OWENS & MINOR, INC.
GLEN ALLEN,  VA ,  US.
OWENS & MINOR WEST, INC.
DENVER,  CO,  US.

OWENS & MINOR WEST, INC.
DENVER,  CO ,  US.
OWENS INDUSTRIES, INC.
OAK CREEK,  WI,  US.
Contract Manufacturer;   Manufacturer;  
OWENS INDUSTRIES, INC.
OAK CREEK,  WI ,  US.
OWENS PRECISION SYSTEMS, INC.
OAK CREEK,  WI,  US.
Initial Importer;   Contract Manufacturer;   Manufacturer;   Remanufacturer;   Repackager/Relabeller;  
OWENS PRECISION SYSTEMS, INC.
OAK CREEK,  WI ,  US.
OWENS-ILLINOIS CLOSURE INC.
PERRYSBURG,  OH,  US.
Specification Developer;  
OWENS-ILLINOIS, INC.
TOLEDO,  OH ,  US.
OWENS-ILLINOIS CLOSURE, INC.
FRANKLIN,  IN,  US.
Contract Manufacturer;   Manufacturer;  
OWENS-ILLINOIS, INC.
TOLEDO,  OH ,  US.
OWENS-ILLINOIS PLASTIC PRODUCTS DE MEXICO S DE RL
TLALNEPANTLA, EDO DE MEXICO,  MX.
Contract Manufacturer;  
OWENS-ILLINOIS, INC.
TOLEDO,  OH ,  US.
OWP BRILLEN GMBH
PASSAU/BAVARIA,  GM.
Manufacturer;  
OWP BRILLEN GMBH
PASSAU/BAVARIA,  GM.
OXAIR LTD.
NIAGARA FALLS,  NY,  US.
Manufacturer;  
OXAIR LTD.
NIAGARA FALLS,  NY ,  US.
OXFORD BIOSIGNALS LIMITED
OXFORD,  UK.
Manufacturer;   Specification Developer;  
OXFORD BIOSIGNALS LIMITED
OXFORD,  UK.
OXFORD INSTRUMENTS MEDICAL, INC.
HAWTHORNE,  NY,  US.
Initial Importer;  
OXFORD INSTRUMENTS, PLC.
EYNSHAM, WITNEY OXON,  UK.
OXFORD OPTICAL
HAMDEN,  CT,  US.
Initial Importer;  
OXFORD OPTICAL
HAMDEN,  CT ,  US.
OXFORD PRODUCTS
COLUMBUS,  OH,  US.
Initial Importer;  
MAZEL STORES, INC.
COLUMBUS,  OH ,  US.
OXFORD SURGICAL, INC.
HOUSTON,  TX,  US.
Initial Importer;  
OXFORD SURGICAL, INC.
HOUSTON,  TX ,  US.
OXIA U.S. LTD.
LAS VEGAS,  NV,  US.
Initial Importer;   Remanufacturer;  
OXIA U.S. LTD.
LAS VEGAS,  NV ,  US.
OXIBIS-EXALTO SAS
MORBIER,  FR.
Specification Developer;  
OXIBIS-EXALTO SAS
MORBIER,  FR.
OXIGENOL
MONTEROTONDO, ROMA,  IT.
Unregistered Foreign Lister;  
OXIGENOL
MONTEROTONDO, ROMA,  IT.
OXIGRAF, INC.
MOUNTAIN VIEW,  CA,  US.
Manufacturer;  
OXIGRAF, INC.
MOUNTAIN VIEW,  CA ,  US.
OXLIFE LLC
NAPLES,  NC,  US.
Manufacturer;  
OXLIFE LLC
NAPLES,  NC ,  US.
OXO EYEWEAR LIMITED
KOWLOON,  HK.
Foreign Exporter;   Contract Manufacturer;   Manufacturer;  
OXO EYEWEAR LIMITED
KOWLOON,  HK.
OXOID, INC.
OGDENSBURG,  NY,  US.
Initial Importer;  
OXOID, LTD.
HAMPTON,  NH ,  US.
OXOID, LTD.
BASINGSTOKE, HAMPSHIRE,  UK.
Manufacturer;  
FISHER SCIENTIFIC INTL.
HAMPTON,  NH ,  US.
OXY-CURE CO., LTD.
GOYANG-SI, KYUNGGI-DO,  KS.
Manufacturer;  
OXY-CURE CO., LTD.
GOYANG-SI, KYUNGGI-DO,  KS.
OXYGEN PLUS, INC.
YPSILANTI,  MI,  US.

OXYGEN PLUS, INC.
YPSILANTI,  MI ,  US.
OXYGEN SERVICE CO., INC.
ORANGE,  CA,  US.
Manufacturer;  
OXYGEN SERVICE CO., INC.
ORANGE,  CA ,  US.
OXYGEN THERAPY INSTITUTE
TALLAHASSEE,  FL,  US.
Manufacturer;  
OXYGEN THERAPY INSTITUTE
TALLAHASSEE,  FL ,  US.
OXYGENICS MFG., INC.
PORT COQUITLAM, B.C.,  CA.
Unregistered Foreign Lister;  
OXYGENICS MFG., INC.
PORT COQUITLAM, B.C.,  CA.
OXYRASE, INC.
MANSFIELD,  OH,  US.
Manufacturer;  
OXYRASE, INC.
MANSFIELD,  OH ,  US.
OXY-SURE COMPANY, LLC.
OROFINO,  ID,  US.
Manufacturer;  
OXY-SURE COMPANY, LLC.
OROFINO,  ID ,  US.

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Last Modified: 29 April 2006
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